Technical Standard No. 82, Version 1-2025 Pharmaceutical Products. Medicines for human use. Bioequivalence and therapeutic equivalence.

Technical Standard No. 82, version 01-2025, seeks to establish requirements for demonstrating the bioequivalence and therapeutic equivalence of multi-origin medicines in order to guarantee their safety, quality and efficacy. It applies to multi-origin medicines manufactured in Guatemala and those imported by natural or legal persons that must demonstrate therapeutic equivalence, for the purpose of applying for and maintaining sanitary registration with the Department for the Regulation and Control of Pharmaceutical and Related Products.